Managing Point of Care in our Hospital

Achieving CPA for POCT

Tony Cambridge, Section Lead for POCT and EQA

The TeamSection Leader

2 x 0.5 wte Specialist Biomedical Scientists2 x Associate Practitioners

0.5 wte ATO

4.5 wte staff members Heather is a bit shy!

Overview of the service

• Blood Gases - 16 analysers across the trust, 14 connected• Glucose – 230 meters, 180 Performa, 50 connected (Inform II, 4 off site)• Urinalysis- 70 sites, 30 Urisys 1100 meters, not connected• Urine Pregnancy Testing- 20 sites, currently all eye read• Hemocue Hb- 6 meters, combination of 201+ and 201DM

We do not have full connectivity (and I don’t expect to ever achieve it!)

The service (and accreditation) covers:the acute trust external sites such as primary care hospitals, MIUs, clinicsUKSH Peninsula Treatment Centre (Care UK)

Not included in the CPA assessment:ESR measurement INR monitoring in GP land

A Bit of History

2000- POCT section was part of the Chemistry Special Investigations section

2006- POCT section created with a section lead (BMS3), deputy (BMS2), BMS and ATO staff with rotation of BMS staff through the laboratory

2008- Rotation of staff through the POCT team removed

2009- Workforce redesign. Reduction of state registered staff in favour of associate practitioners

2011- Further changes to the team including addition of an ATO

2012- (January) CPA Pre-Assessment visit

(July) CPA 2 day Assessment (3 assessors)

Pre-Assessment

-£750, one day

-regional assessor

-gap analysis

-action plan

-Full assessment booked

Contents

1. Quality Management System (QMS)2. Training and Competency3. Governance of POCT4. Communicating5. Equipment6. Planning and Review7. Quality Assurance8. Parting message

Quality Management System (QMS)A4.4 Laboratory management shall establish a quality management system for POCT

We use QPulse version 5.6Modules:Documents- 115 SOPs, Policies, Quick guides, Training notes, COSHH. All controlled with document name, number, version and issue date. Marked as controlled documents ‘valid on day of printing only’.

Audit- A programme of monthly audits is held on the audit calendarH&S audit, Training audit, Ward Temperature audit,

Cleanliness audit, Review of BGA IQC-Audit Database, target is 20 sites per month

CAPA- Corrective/Preventive Action. This is where all non-conformance and non-compliance is registered and

addressed following audit

Key Documentation

• POCT Policy• POCT Quality Manual• POCT Audit Policy• POCT Training Policy (referencing the Medical Devices Training Policy)

• Service Level Agreement (A2.5 POCT formal agreement with other healthcare organisations)

Others:POCT Control of Reagents and ConsumablesPOCT Sample HandlingPOCT Quality Control PolicyPOCT Patient Result ReportingPOCT ConnectivityPOCT Test Lot Verification ProcedureWritten ahead of the pre-assessment!

Training and Competency

-CPA Standard B9 Staff training and educationThe standard is met by providing initial face to face training which is recorded in Oracle Learning Manager (OLM)

Training for all POCT equipment is delivered by the POCT team, Link Trainers or Manufacturer’s trainers.

Competency is assessed through eLearning delivered through use of OLM (presentation followed by Q&A)

Access to equipment is withheld until competency is established.

Governance of POCTA1.8 The organisation within which POCT is provided shall ensure that there

is a POCT governance group responsible to its top management….

Governance of POCT• POCT Management Group (A1.9/B1.6 (POCT))

This group is responsible for the day-to-day operational issues of POCT.- defines responsibilities and authority of POCT personnel- ensures that training and competency testing is provided- assesses new devices/systems (comparability with laboratory)

• POCT Governance Group (A1.8 (POCT))The membership of the group have clinical backgrounds, nursing, technical, procurement, pharmacy, medical devices, training, paediatrics and midwifery.

This group defines the scope of POCT with particular emphasis on:- clinical need- financial implications- technical feasibility- resources available-review of non-conformance

CommunicatingHealthnet Pathology POCT page (intranet) – Documents and key info available here for all staff to view/download/print

POCT Newsletter – quarterly, keeps users informed of key issues

Vital Signs – Weekly trust document emailed to all staff. We advertise training sessions here

Daily email – On occasion we may send out information through the press office daily email

EQA Performance sheets - We include training dates, performance issues etc., on these sheets

Non-Conformance reports – A printout is delivered to managers for communication to staff

Audit findings – A report is generated and sent to managers for action. Audits remain open until a satisfactory response is received

Communication Boards

Equipment

The selection process for all POCT devices has to be documented.-Evaluation of the technology

-Validation of results

-Cost/Clinical effectiveness

-Implementation of the equipment/service

-Must have comparability data for all tests performed at the point of care that are also available in the lab. (F3.6)

-If a device changes mid-contract i.e. Accu-chek Advantage to Performa or Inform to Inform II you must evaluate the results.

The manufacturer’s data is not good enough for CPA.

Planning and ReviewA11.4 Laboratory management shall conduct an annual review of POCTB1.7 The laboratory director or designee shall implement a periodic review of POCT activities

Objectives are set on an annual basis which are then reviewed in the following ways:-An Annual Management Review (AMR) is conducted for POCT which is also incorporated in the Lab AMR. Success is measured by looking at -clinical need

-clinical effectiveness

-cost effectiveness of the service

-has the service delivered its objectives

-Clinical incidents, non-conformance data

-3 month review of the POCT service by the clinical lead for POCT or other designee (me!)

Quality AssuranceH5.5 There shall be participation in EQA schemes. Where such a scheme is not available an alternative internal quality assessment scheme shall be implemented

-Glucose meters, blood gas analysers and hemocues are in traditional EQA schemes (WEQAS/NEQAS)

-Urinalysis and urine pregnancy testing are not

Why? Too expensive, too time consuming, how do we comply?

-In house spiked quality assurance sample distributed to sites

-The batch undergoes a verification procedure plus stability checked

-Laboratory urinalysis meters enrolled in EQA scheme only

-Commercial IQC sample performed on lab meters prior to testing in house QA sample.

-Results compared in an Access database

Parting message-Don’t fear the process, book a pre-assessment.-Develop a dedicated POCT team (be single minded regarding your goals).-Get the support of management and clinical leads.-Establish an effective QMS.-Ensure that your governance structure meets the standards.-Have a robust audit programme in place.-Review non-conformances, take action-Review your reviews!-Don’t have full connectivity? It shouldn’t matter.-Communicate with, and involve users in the service.

And Good Luck. Thanks for listening!